Neurobo Pharmaceuticals Receives First Site IRB Approval for a Phase 2a Clinical Trial Evaluating DA-1241 as a Potential Treatment for NASH
Friday, August 04, 2023
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a biotechnology company in the clinical-stage, is dedicated to addressing cardiometabolic diseases. The company recently obtained Institutional Review Board (IRB) approval for the Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for treating nonalcoholic steatohepatitis (NASH). The trial is set to commence in September 2023 at the Inland Empire Liver Foundation in Rialto, CA, under the supervision of Dr. Zeid Kayali.
The CEO of NeuroBo, Joe Hooker, expressed enthusiasm about reaching this significant milestone in the development of DA-1241. Previous clinical studies have demonstrated the compound's favorable tolerability in both healthy volunteers and patients with type 2 diabetes mellitus (T2DM). Additionally, preclinical studies in animal models have indicated that DA-1241 may be effective in reducing hepatic steatosis, inflammation, fibrosis, and improving glucose control.
The Phase 2a trial of DA-1241 is designed as a 16-week, multicenter, randomized, double-blind, placebo-controlled study to evaluate its efficacy and safety in subjects with presumed NASH and confirmed pre-diabetes or T2DM.
Part 1 of the trial will focus on evaluating DA-1241's efficacy compared to placebo. It aims to enroll 49 subjects, with a planned maximum of 55 to account for potential early discontinuations. Subjects will be randomly assigned to three treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.
Part 2 of the trial will examine the efficacy of DA-1241 in combination with sitagliptin versus placebo. Enrollment of 37 subjects is expected, with a maximum of 43 to account for potential early discontinuations. Subjects will be divided into two treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo. Part 2 will begin after a confirmatory preclinical safety study of the combination therapy.
The primary endpoint for both parts of the trial will be the change in alanine transaminase (ALT) levels from baseline at Week 16, while other secondary efficacy endpoints will also be monitored.
DA-1241 is a novel GPR119 agonist that holds promise as a potential standalone or combination therapy for NASH and T2DM. Its mechanism of action, involving the release of beneficial gut peptides, has shown positive effects on liver inflammation, lipid metabolism, weight loss, and glucose metabolism in preclinical studies. Previous Phase 1a and 1b trials have established its good tolerability in both healthy volunteers and T2DM patients.
